We are Merlin Digital Partner, a leading IT and Digital headhunting company with over a decade of experience. We've successfully collaborated with industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial.
Our emphasis lies in people-centric approaches and optimizing selection processes. Our mission is to revolutionize companies by seamlessly integrating top-tier talent. We are currently looking for a Specialist Regulatory Compliance (PRRC).
The Mission:
The Person Responsible for Regulatory Compliance (PRRC) ensures that the company's medical device products are in full compliance with the European Union's Medical Device Regulation (MDR) 2017/745 and the requirements of ISO 13485. The PRRC is critical in maintaining the company’s commitment to regulatory compliance and product safety.
The Role:
* Oversee the regulatory compliance of all medical devices, ensuring conformity with MDR and ISO 13485.
* Liaise with Notified Bodies and Competent Authorities for regulatory matters.
* Ensure the technical documentation and EU Declarations of Conformity are up to date and compliant.
* Supervise post-market surveillance and vigilance activities, ensuring timely reporting of incidents.
* Monitor compliance with the requirements concerning the qualification and classification of medical devices.
* Conduct internal audits to verify compliance with regulatory requirements.
* Participate in strategic planning and provide regulatory guidance.
* Ensure all staff are informed of regulatory obligations and changes in regulations.
* Maintain an in-depth understanding of global medical device regulations and standards.
* Ensure that the distribution of medical devices within EU member states complies with the regulatory requirements, including oversight of post-market surveillance, vigilance, and maintaining traceability throughout the supply chain.
Key Activities:
* Keep abreast of regulatory updates and interpret changes to ensure company-wide compliance.
* Collaborate with D&D, Quality Assurance, and other departments to ensure regulatory considerations are integrated into the product lifecycle.
* Manage the preparation and submission of regulatory filings and registrations.
* Facilitate training programs on regulatory requirements for employees.
* Act as the point of contact for regulatory authorities and Notified Bodies.
What we expect from you:
* Bachelor’s or Master’s degree in life sciences, engineering, legal, or another relevant field.
* At least 2 years of experience in regulatory affairs within the medical device industry.
* Detailed knowledge of MDR 2017/745, ISO 13485, and related regulatory frameworks.
* Experience interacting with regulatory authorities and Notified Bodies is preferred.
* Previous experience in a compliance or regulatory leadership position is advantageous.
* Strong analytical and strategic thinking skills.
* Excellent communication skills with the ability to articulate regulatory requirements.
* Thorough and meticulous with documentation.
* Leadership skills with the ability to influence and drive organizational compliance.
* Proactive and capable of working independently.
* Good command of the English language.
Benefits:
* Opportunities for professional growth and career advancement.
* A dynamic, innovative work environment where creativity and new ideas are encouraged.
* Flexible working environment.
Are you ready to be part of the challenge? Contact us!
Please note that this is a Hybrid position (Full time: 40 hours/week)
(On-site 3 days a week in San Sebastian) + Occasional travel may be required for meetings with regulatory bodies or industry events.
#J-18808-Ljbffr